WO2011047672A1 - Dispositif chirurgical permettant de guider au moins un fil de suture à travers la zone périphérique d'une ouverture tissulaire d'un patient et procédé d'actionnement d'un tel dispositif - Google Patents

Dispositif chirurgical permettant de guider au moins un fil de suture à travers la zone périphérique d'une ouverture tissulaire d'un patient et procédé d'actionnement d'un tel dispositif Download PDF

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Publication number
WO2011047672A1
WO2011047672A1 PCT/DE2010/001243 DE2010001243W WO2011047672A1 WO 2011047672 A1 WO2011047672 A1 WO 2011047672A1 DE 2010001243 W DE2010001243 W DE 2010001243W WO 2011047672 A1 WO2011047672 A1 WO 2011047672A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
receiving
distal end
thread
opening
Prior art date
Application number
PCT/DE2010/001243
Other languages
German (de)
English (en)
Inventor
Peter Paul Fink
Original Assignee
Medi-Globe Vascutec Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medi-Globe Vascutec Gmbh filed Critical Medi-Globe Vascutec Gmbh
Priority to EP10784675A priority Critical patent/EP2490596A1/fr
Priority to US12/998,782 priority patent/US20110230899A1/en
Priority to DE112010004777T priority patent/DE112010004777A5/de
Publication of WO2011047672A1 publication Critical patent/WO2011047672A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482Needle or suture guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0466Suture bridges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/062Needle manipulators
    • A61B17/0625Needle manipulators the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00663Type of implements the implement being a suture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472Multiple-needled, e.g. double-needled, instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2946Locking means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2948Sealing means, e.g. for sealing the interior from fluid entry

Definitions

  • the invention relates to a surgical device for passing at least one sewing thread attached to a sewing needle through the edge region of a tissue opening possibly formed by cutting in an artery of an individual and retracting the respective end of the thread passing through the respective edge region from said opening.
  • a rod-shaped needle receiving and guiding device in which the needle connected to the respective sewing thread is received and guided in a receiving and guiding opening such that it can be moved from a pushing device arranged towards the proximal device end to a needle receiving region at the distal device end over a gap region which has a length corresponding at least to the thickness of the wall of the tissue opening and an outer shape reduced relative to the outer shape of the needle receiving and guiding device for unimpeded movement of the respective needle from the needle receiving and guiding device to the distal end of the device,
  • the invention relates to a method for actuating such a device.
  • the thread guide device in its longitudinal direction on a proximal Fadenzu operationsteil, a distal thread receiving part and an intermediate middle Fadenuza- / thread clamping part.
  • Said middle Fadenkekie- / Fadenklemmteil is rotatable at least relative to the distal thread receiving portion and has a cross section that allows in at least one rotational position, the introduction of the supplied from the provided at the proximal end of the device Fadenzu Equipmentungs Nähfaden in exposed in the thread receiving part receiving openings and in a from the said rotational position different rotational positions of the recorded in the respective receiving openings together with the needles sewing threads for pulling out the entire yarn guide means from said opening to hold out.
  • Such an easier-to-use surgical device is known from DE 10 2004 041 936 B3.
  • the needle delivery region, the gap region and the needle receiving region of the rod-shaped needle and thread guiding device are rigidly connected to each other.
  • the rod-shaped needle and thread guiding device can be closed by an elongated outer member which surrounds the interspace region in a form-fitting manner and which is displaceable in the longitudinal direction thereof, releasing the said interspace region relative to the rod-shaped thread guiding device.
  • the suture feed device includes suture needles having cranked needle tip portions that are initially in a radially collapsed condition and each include suture material received from a needle eye.
  • the suture-receiving device consists of an inflatable balloon-like structure of arcuately bulging elements or of an elastomer.
  • the balloon-like structure is widened, so that it can no longer be pulled out of the tissue opening in this state.
  • sewing needles of the suture feed device are pivoted with their crooked needle tip parts, each containing in a Nadelschreib suture, in a crank-like movement from a collapsed position to a radially outward position in which they at a distance from the edge region of the tissue opening through the Tissue are inserted into the balloon-like structure.
  • this balloon-like structure only the suture is held by the balloon-like structure of the suture receiving device is returned to its collapsed state.
  • the sewing needles themselves must then be withdrawn from the suture material.
  • FIG. 99/012480 A1 WO 99/025254 A1
  • FIG. 99/012480 A1 WO 99/025254 A1
  • FIG. 99/012480 A1 WO 99/025254 A1
  • FIG. 99/012480 A1 WO 99/025254 A1
  • FIG. 99/012480 A1 WO 99/025254 A1
  • This collapsed structure is then pulled together with the suture held by him from the tissue opening out to the proximal end device.
  • contraction and knotting of the so through the fabric edge region of the tissue opening to be closed and through this tissue opening extending suture the respective tissue opening can then be closed.
  • the hollow needles must be removed from the suture material and withdrawn from the tissue opening to be closed before the expandable for receiving the suture material and after its inclusion refoldable structure is pulled out of the tissue opening. Otherwise, in this case as well, the tissue between the piercing points of the hollow needles would be torn by the edge region of the tissue opening and the tissue opening.
  • the design effort required for the realization of the last-mentioned known devices for closing wounds is regarded as relatively complicated, in particular with regard to the thread take-up spreader part and the barbed sewing needles.
  • the mechanism for detecting the suture ends received by the suture take-up spreader through the barbs of the suture needles requires a relatively accurate control of the respective suture tension so that the respective suture ends can be grasped by the barbs of the suture needles.
  • Another known sewing device has a needle carrier to be inserted into a tissue opening to be occluded and a needle receiving device located outside the respective opening.
  • the needle carrier has two curved needles, which are connected at their one ends to the two ends of a sewing thread. At their other ends the needles are formed with points and their area provided barbs.
  • the needle receiving device consists of an expandable cage structure. In operation, the needle carrier is first completely inserted through the tissue opening of a blood vessel to be closed in this.
  • the needles are guided through the edge region of the relevant tissue opening from the inner region of the blood vessel containing the tissue opening to the outside through the vessel wall surrounding the tissue opening, with radial spreading.
  • the remaining needle carrier parts initially remain in the blood vessel. Thereafter, however, these needle carrier parts are withdrawn with the sewing threads connected to them from the blood vessel through the tissue opening, so that in the blood vessel only the sewing thread part connected to the needles that has already been led out remains.
  • the needles are inserted with their barbs in the now expanded outside of the tissue opening to be closed cage structure and held by their subsequent contraction. By then retracting the contracted cage structure with the needles held therein, the suture portion connected to its ends with these needles is finally tensioned inside the aforementioned blood vessel, so that thereafter the suture ends can be knotted. This will then close the relevant opening.
  • the known device which has just been considered permits, in principle, sewing threads through the wall of a blood vessel near the edge region of an opening provided therein.
  • the safety in connection with the inclusion of the needle ends in the needle receiving device may be at least critical. Namely, if one or the other needle is not received safely by the needle receiving device, complications are not excluded in this case and possibly additional intervention is necessary, which is considered undesirable.
  • access to the blood vessel, in particular to the artery must be expanded here. However, this makes a minimally invasive use of the relevant known device more difficult.
  • the invention is therefore based on the object, a device and a method of the type mentioned in such a way that both a simpler and a secure recording of at least one passed through the fabric edge of a fabric opening, a sewing thread leading with sewing needle can be achieved.
  • the above-mentioned object is achieved in a surgical device of the type mentioned according to the invention in that the needle receiving portion of the rod-shaped Nadelfact- and needle guide device by a distal end of the device attached and compressible around a Llvesianuteil in a device longitudinal direction and stretchable in a device longitudinal direction opposite braid is formed, which allows to accommodate the respective needle in a compressed mesh formed by the compression inner space in the compressed state and after such a needle holder by its subsequent stretching only surrounds the needle in question and holds.
  • the invention has the advantage that the respective sewing needle can be picked up and held in a simpler, but nevertheless secure manner by the needle receiving and needle guiding device after its piercing of the edge region of a tissue opening than in the known sewing devices considered above.
  • the retention of the respective needle is preferably carried out by a positive connection by means of the re-stretched braid after previously made needle recording.
  • the invention is advantageously suitable for a minimally invasive use for closing a tissue opening of an individual.
  • the respective sewing thread extends from a stationary device grip part into a single sewing thread channel, in particular close to the device outside, to the distal end region of the needle receiving and needle guiding device and from there to its associated needle.
  • the needle receiving and guiding device for each needle has a separate guide channel, which is provided near its distal end with an insertion opening at least for the introduction of the sewing thread connected to the respective needle.
  • This measure facilitates both the insertion of the respective sewing needle with its sewing thread into the Nadelfact- and needle guide device and the handling of the respective sewing thread in the case of its tearing off the associated in said mesh interior form-fitting captured sewing needle.
  • a further expedient embodiment of the invention consists in that the respective sewing needle can be displaced from a position adjacent to the stationary device handle part into a position toward the distal end of the device by means of a needle slide device, which is displaceable on the needle receiving and needle guide device. Due to the configuration, there is the advantage of a structurally particularly easy to implement displacement of the respective sewing needle.
  • the displaceability of the respective needle is only then released, when the braid is compressed to form the mesh interior.
  • the respective sewing needle can only be moved if it can be positively recorded and held by the mesh. The risk of injury when handling the thus configured surgical device prior to its use for passing at least one suture through the edge region of a particular in an artery of an individual is thus practically impossible.
  • a release / locking mechanism is provided between the fixed device handle portion and a rotating device adjacent thereto for releasing or disabling displacement of the respective needle.
  • the use of such a release / locking mechanism has the advantage of securely blocking the displaceability of the respective needle.
  • the release / locking mechanism on a male part with a certain outer shape and a receiving part with a respective outer shape corresponding inner shape which allows to receive the male part in a fixed rotational position of male part to female part; while the male part or the receiving part with the rotating device and the receiving part or the male part with the fixed device handle part are connected.
  • the rotator is connected to the fixed device gripping member by a translator translating a translational motion converting means, which comprises rotating the rotator together with the latter whose circumferential direction rotating pin device and a rotational movement in a longitudinal movement converting sliding part), through which the braid is compressible to form its braid interior.
  • the rotator at the proximal end of the device is disposed adjacent to the fixed device handle portion, and the slide member is disposed adjacent the distal device handle portion toward the distal end of the device.
  • a method for operating a surgical device for passing at least one attached to a suture needle thread through the edge region of an existing in particular in an artery of an individual, optionally formed by cutting tissue opening and retraction of the respective suture end passed through the respective edge region from said opening, the needle connected to the respective suture being received and guided in a receiving and guiding opening of a rod-shaped needle receiving and guiding device so as to move from a pushing device towards the needle receiving area towards the proximal end of the device at the distal end of the device is moved over a gap region having a length at least equal to the thickness of the wall of the tissue opening and a relative to the outer shape of the Nadelfact- and needle guide device for unimpeded movement of the respective needle from the needle receiving and needle guide device to the distal end of the device down reduced external shape, wherein the respective needle is moved after passing through the edge region of the tissue opening in question in the needle receiving portion for permanent recording there wherein thereafter the rod-shaped Nadelability- and needle guide
  • This method is characterized in that the measures taken by the needle receiving area of the rod-shaped needle receiving and needle guiding device taken respective Nähnadel inserted through the attached to the distal end of the device and compressible around a longitudinal body part in a device longitudinal direction stretchable in a device longitudinal direction braid in its compressed state in a formed by the compression braid interior and after such needle pickup by subsequent stretching of the mesh is enclosed by this and held.
  • This handling preferably allows a one-handed operation of the device in question, by the re-stretched braid after previously taken needle recording, the respective needle is held in this braid preferably by positive locking.
  • FIG. 1 is a schematic plan view, not to scale, of a surgical device according to one embodiment of the present invention in a partially open condition in a first position with a sliding member in a first position.
  • FIG. 1 is a schematic plan view, not to scale, of a surgical device according to one embodiment of the present invention in a partially open condition in a first position with a sliding member in a first position.
  • FIG. 2 shows, in a somewhat enlarged plan view, the largely open proximal region of the device according to FIG. 1 with the sliding part located in the first position.
  • FIG. 3 shows, in a somewhat enlarged plan view, the largely open proximal region of the device according to FIG. 1 with the sliding part located in a second position.
  • FIG. 4 shows the opened region of the device according to FIG. 1 in the illustrated in FIG. 3 in a perspective view with a needle slider device in a first position.
  • FIG. 5 shows the open region of the device according to FIG. 1 shown in FIG. 3 in a perspective view with the needle-slide device in a second position different from the first position.
  • Fig. 6 shows in a perspective view the formation of a rotary member at the open proximal end of the device with the sliding part removed.
  • Fig. 7 shows an enlarged plan view of the detail of the highlighted in the apparatus of FIG. 1 area A as a to a Needle receiving area belonging braid in the extended state at the distal end of the device.
  • FIG. 1 Area A shows in an enlarged plan view the detail of the highlighted in the apparatus of FIG. 1 Area A as belonging to the needle receiving area in the compressed state at the distal end of the device to form a braid interior, in which needles containing needles in the second position of the sliding part for followed by a subsequent capture recorded or recorded.
  • Figure 1 shows in an enlarged perspective view the area A of the braid in the compressed state at the distal end of the device, together with needles received by the braid, and highlighted in the device of Figure 1, showing the course of sewing threads connected to the needles.
  • Figure 1 shows in greatly enlarged perspective views of the course of sutures that have been passed by four needles through the edge region of a tissue opening to be closed and then pulled together with their connected to the needles sewing thread ends by means of the device of FIG. 1 from the tissue opening.
  • FIG. 1 shows from a further embodiment of the surgical device according to the present invention, the largely open proximal portion of this device in a perspective view with a needle shifter.
  • FIG. 4 shows in a perspective view a detail of the shown in Fig. 4 further embodiment of the surgical device according to the present invention together with a removable locking or locking member.
  • FIG. 14 and 15 shows in a greatly enlarged perspective view of a used in the shown in Figs. 14 and 15 further embodiment of the surgical device according to the present invention thread take-up device with a bobbin and a receiving this coil receiving body.
  • FIG. 16 shows a perspective sectional view of the thread receiving device shown in Fig. 16 with a section below an upper cover plate of the bobbin.
  • FIG. 18 shows in a greatly enlarged sectional view the distal end region of the device according to FIG. 1.
  • a surgical device 1 according to an embodiment of the present invention is shown in a non-scale schematic plan view.
  • the part of the device 1 shown on the right in FIG. 1 illustrates a half shell of the device 1 - ie the device 1 in an opened state.
  • the device 1 preferably consists of two half-shells, which can be joined together by latching and / or screwing to a closed housing part.
  • the housing part of the surgical device 1 contains in a central region in FIG. 1 a fixed grip part 2, to which a rotary part 3 is connected to the proximal end region shown to the right and to the distal end region shown on the left a needle slide 4 representing a needle pushing device.
  • This needle shifter 4 serves, as will be seen in more detail below, for moving sewing needles, which are not visible in FIG. 1 - hereinafter referred to as needles for short in each case.
  • These needles, together with the ends of sewing threads are accommodated in the distal end region of a rod-shaped or tubular needle receiving and guiding device 5, which adjoins the needle shifter 4 towards the distal end of the device.
  • This needle receiving and guiding device 5 in a practical embodiment in a tubular configuration, has an outer diameter of, for example, not more than 20 FR (French), that is about 6.7 mm.
  • the needle receiving and needle guiding device 5 is adjoined at the distal end of the device by a needle receiving device 6 which has a longitudinal body part 7 which can be seen in FIGS. 7 and 8 and which can be displaced in the longitudinal direction of the device 1, and a distal end part 8 with a truncated cone towards the distal end formed course and a compressible in the longitudinal direction of the device 1 and in a direction opposite device longitudinal direction stretchable braid 9, as is more apparent from Fig. 7, 8 and 9.
  • a material for the thin wires or strands is preferably stainless steel or another biocomp . atibles braid material used, which can be brought from a stretched shape in a compressed form in which it is widened transversely to the longitudinal axis of the device 1 and forms a mesh interior.
  • the mesh 9 is closely meshed in the stretched state, and it is beaumaschig in the compressed and thus expanded state.
  • the braid 9 may preferably be coated with an anti-slip material, at least on its side facing the longitudinal body part 7, such as with an elastomer.
  • an anti-slip material such as an elastomer.
  • the wires or strands of the braid 9 itself consist of such an anti-slip material, such as an elastomer.
  • the longitudinal body part 7 has an outer dimension which is reduced in relation to the outer dimension of the distal end part 8; these outer dimensions are at a round design of these parts 7, 8 whose outer diameter.
  • 9 needles 11 can be enclosed and held in the region of the longitudinal body part 7 within the mesh according to FIG. 7.
  • the respective braid 9 is here in each case firmly connected to the distal end part 8 and to the distal end of the needle receiving and needle guiding device 5.
  • the widened mesh interior with the now wide-mesh 9 allows to receive needles 10 connected needles 1, as shown in FIGS. 8 and 9 can be seen.
  • this is brought into a shape corresponding to that shown in FIG. 7 - ie stretched again.
  • the needles 11 are now enclosed by the mesh 9 and thus held in a form-fitting manner.
  • the needles 1 can then no longer be pulled out of the braid 9 by exerting a tensile force by means of the sewing thread ends or sewing threads 10 connected to them.
  • the braid 9 in a practical embodiment in its stretched state has an outer diameter of, for example, not more than 2FR in its tubular configuration, that is 4 mm.
  • the needles 11 can be pushed out of needle-dispensing areas of the needle-receiving and needle-guiding device 5 close to the edge.
  • These near-edge needle delivery areas of the needle receiving and needle guiding device 5 define a gap area 12 in connection with the area of the non-compressed mesh 9.
  • This intermediate space region 2 on the one hand, has at least one length corresponding to the thickness of the wall of the tissue opening.
  • the gap region 12 has such an outer shape, which is reduced relative to the outer shape of the Nadelfact- and needle guide device 5 for an unobstructed movement of the respective needle 11 from the Nadelfact- and needle guide device 5 to the distal end device. This means that the respective needle 11, together with the sewing thread end 10 fastened to it, can be guided at some distance from the edge of the respective fabric opening through its edge region.
  • an insertion tube 13 in particular made of plastic, metal or a composite material, which extends through the device 1.
  • this insertion tube 13 in conjunction with the end part 8, which is embodied as a truncated-cone-shaped end toward the distal end, facilitates insertion of the distal end of the device 1 into a tissue opening of an individual to be occluded.
  • the relevant insertion tube 3 facilitates the reception of a guide wire shown in FIG.
  • the insertion tube 13 is positioned immovably, in particular in the longitudinal center of the device 1.
  • the pitch between the needles diagonally opposite with respect to the tissue opening to be closed is preferably 16FR (which is 5.3 mm).
  • the aforementioned insertion tube 13 which preferably consists in the distal end region of the device 1 of a flexible plastic tube, such as a polyamide and in the proximal end portion of the device 1 of a metal tube, the above-mentioned distal end portion 8 may be firmly applied;
  • the longitudinal body part 7 may be formed by a portion of the insertion tube 3.
  • FIG. 2 illustrates the largely open proximal region of the device 1 in a slightly enlarged plan view and with a sliding part 14 in the same position as in FIG.
  • a plug-in part 16 belonging to a release / locking mechanism 15 for a needle displacement is housed with a certain outer shape and a receiving part 17 in the form of a turntable having such a certain inner shape or receiving opening that the outer shape in a fixed allowed to record relative rotational position of male part 16 to receiving part 17 and turntable, as is apparent from the perspective view of FIG.
  • the release / locking mechanism 15 therefore corresponds to the principle of a normal key and a matching keyhole of a lock.
  • the receiving part 17 and the turntable as a rotatable part is here connected to the rotary member 3, and the male part 16 is, as will be explained in detail, in the fixed handle part 2 only in the longitudinal direction of the device 1 by means of a hollow tube connected to him 23 a further hollow tube 25 connected thereto and a coupling mechanism 28 connected to the needle pusher 4 are displaceable when the outer shape of the plug-in part 16 and the receiving opening of the receiving part 17 or the turntable are in coincident positions.
  • the male part 16, the mentioned hollow tubes 23, 25, the coupling mechanism 28 and the Nadelschieber4 are firmly connected to each other here. It should be noted, however, that in principle, the receiving part 17 could not be rotated and that the male part 6 could be arranged rotatable. It is only important that a relative rotation between the male part 16 and the receiving part 17 or rotary part is made possible.
  • a motion conversion device 9 which converts a rotational movement of the rotary member 3 into a translatory movement.
  • These movements tion conversion device 19 has the already mentioned sliding part 14, which is provided here as a cylindrically shaped part, in the cylinder outer wall at least one thread 20 is provided which extends over a predetermined angular range, such as 90 ° or 180 ° the relevant cylinder outer wall extends.
  • a parallel second thread corresponding thereto 21 is provided in addition to the thread 20, a parallel second thread corresponding thereto 21 is provided.
  • the respective thread 20, 21 here preferably has a quadrangular, such as trapezoidal cross-section. However, the cross-section could also be designed differently, such as triangular.
  • the considered motion-Umsetz- device 19 basically works with only one thread 20 or 21 in the sliding part 14 and a pin member 22 in one of the shell halves of the rotary member 3.
  • a pin member 22 in each shell half of the rotary member 3 and by receiving the one pin member 22 of the thread 20 and the other pin member 22 of the other thread 21 is a structurally particularly simple and lightweight, the means jam-free to be operated motion converter 19 available.
  • the already considered insertion tube 13 is mechanically firmly connected. As mentioned, this insertion tube 13 passes through the device 1 to its distal end.
  • the braid 9 is moved by exerting a pulling movement on the connected to the distal end of the braid end portion 8 of FIG. 7 apparent extended position in the apparent from Fig. 8 and 9 shown upset position. In this compressed position of the Braids 9 can be inserted through the stitches in the thus formed braid interior needles 11, as shown in Figs. 8 and 9 is illustrated.
  • These needles 11 are connected to the suture ends 10 extending from the fixed device handle 2 in a single suture channel 24, particularly near the device exterior, to an exit port 31 in the distal end region of the needle receiving and guiding device 5 and therefrom extend to their respective associated needle 11.
  • the suture channel 24 is here positioned in the outer peripheral region of the needle receiving and needle guide device 5 between two needle receiving openings.
  • Fig. 3 illustrates the situation of the sliding part 14 after rotation of the rotary member 3 by the predetermined angle value, so for example by 90 ° or 180 °.
  • the needle shifter 4 can then be moved towards the distal end of the device 1, as shown in FIG. 5 in comparison to FIG. 4.
  • this receiving part 17 is now rotated relative to the male part 16 so that now the male part 16 of the receiving part 17, more precisely of the opening by moving to the distal end device slidably received. This is apparent from the perspective views of FIG. 4 and 5 in comparison to FIG. 6.
  • the insertion tube 13 may be provided with guide plates 26 which slide in lateral longitudinal slots of the hollow tube 25 and which guide between seen in the half-shells mentioned holding and guide posts 27 are guided.
  • both the insertion tube 13 and the hollow tube 25 can then be displaced only in their longitudinal directions, but not rotated about their longitudinal axes.
  • a twisting of the mesh 9 is avoided. It should be noted here that in principle in .
  • the device 1 according to the invention could be done without the aforementioned guide plate 26.
  • the hollow tube 25 is connected by means of a coupling mechanism 28 with the needle valve 4.
  • This needle shifter 4 can move the needles 11 connected to the ends of the suture 10 in the rod-shaped needle receiving and needle guiding device 5 toward the distal end of the device 1 when the rotary member 3 is in the rotational position shown in FIGS. 4 and 5. In this rotational position is then the sliding part 14 in the apparent from Fig. 3 position in which the mesh 9 is in the compressed state, as shown in FIGS. 8 and 9 can be seen.
  • thread bobbins 29, 30, on each of which either individual threads or a thread loop (not shown) are wound or is.
  • the thread ends of individual threads wound on the thread bobbins 29, 30 or the thread ends of the thread loop wound on the thread bobbins 29, 30 are connected to the needles 1 mentioned above.
  • These needles 1 are relatively short and substantially elongated surgical suture needles, as can be seen in FIGS. 8 and 9. In these FIGS. 8 and 9, the threads or thread ends are each denoted by 10.
  • the respective needles 1 preferably have a relatively thin cylindrical longitudinal body of a solid material, in particular stainless steel with a diameter of, for example, 0.7 mm and a distal sharp needle point.
  • a thread end 10 is connected to the cylindrical longitudinal body of the respective needle 11, for example by means of an adhesive and / or clamping connection.
  • the threads used in the distal device end in the present embodiment with a total of four ends of two suture threads 10 are received by a single thread channel 31, which is located in or on the peripheral area of the needle receiving and needle guide device 5 as shown in FIG.
  • this thread channel 24 the respective sewing threads 10 and their ends extend to their thread bobbins 29, 30 in the stationary handle part 2.
  • the individual needles 1 1 associated Nadelage- and needle guide channels in addition to the recording the connected to the respective needles 11 ends of sewing threads 10 could be shared, so in each case for a needle sewing thread combination.
  • the individual sewing threads 10 or their ends are laid out in a very special way after they have emerged from the outlet opening 31 of the thread channel 24.
  • the respective manner of thread laying is determined in the case of wound on the two bobbins 29, 30 in the stationary handle part 2 thread loops, in what way their connected to the needles 11 ends of the sewing threads 10 through the edge region of a tissue hole to be closed guided and then pulled out of the fabric hole out.
  • FIGS. 10 to 13 illustrate four different types of yarn laying with respect to a fabric hole 32 to be closed.
  • FIGS. 10 show and FIG. 11 shows two cases in which the respective thread loop 33, 34 extends diagonally across the fabric hole 32 to be closed between every two holes that have been stung by two needles.
  • 12 and 13 show two cases in which the respective thread loop between two adjacent, pierced by one needle holes 35, 36 and 37, 38 of the closure hole to be closed 32 between two holes 35, 38 and 36, 37 or 35, 36 and 37, 38.
  • the respective fabric hole 32 in each case one of the yarn ends of the yarn loops 33, 34 crossed in the case of FIGS. 10 and 11 and in each case one of the yarn ends of the yarn loops 33, 34 running in parallel directions in the case of FIGS and then knotted. In this way, the respective fabric hole 32 can be closed safely and reliably.
  • the thread loops 33, 34 run parallel to one another, so that in this case too, the same sewing thread ends can each be pulled together and then knotted together as in the case of FIG.
  • the sewing thread course shown in FIG. 3 differs from the sewing thread course shown in FIG. 2 only in that suture ends 39 and 40 of the loop part 34 are pulled out of the tissue opening 32 through the other loop part 33. In this case too, the same sewing thread each are contracted and then knotted together as in the case of FIG.
  • FIGs. 14 and 15 of the further embodiment of the surgical device according to the present invention in each case substantially only the open proximal region is shown in a perspective view with a sliding rod 25 'coupled to a needle slider device.
  • This push rod 25 ' can be pulled to the distal end of the device by means of the needle pusher 4, after a plug-in part not shown in detail in FIG. 14, which corresponds to the plug-in part 16 shown in FIGS. 2, 3, 4 and 5, can be passed through a receiving part 17' , which has an inner shape that is similar to a keyhole of a normal box lock.
  • This receiving part 17 ' corresponds in function to the receiving part 17 shown in FIGS. 2, 3, 4 and 5.
  • the receiving part 17 ' is, as in the first embodiment shown in FIGS. 2, 3, 4 and 5, connected to a motion converting device corresponding to the motion converting device 19 provided there and is thus rotated when the rotary part 3 is rotated at the proximal end of the device.
  • the rotary part 3 with its rotary movement does not act directly on the sliding part accommodated in it, which corresponds to the sliding part 14.
  • a driver part 46 is provided, which preferably consists of two shell halves and which is firmly held in the rotary part 3.
  • the driver part 46 can only turn together with this after its inclusion in the rotary member 3.
  • the driver member 46 is equipped on its inside with at least one pin device or a pin member corresponding to the illustration of FIG. 6 in the first embodiment to engage in an associated thread of the sliding part 14 corresponding sliding part.
  • FIG. 14 and also in FIG. 15, a coil receiving body 47 and a thread spool 48 are shown, which are placed flat in the middle grip part of the device. were brought.
  • the thread bobbin 48 a number of sewing threads corresponding to the number of sewing needles contained in the device are accommodated with their one ends wound up.
  • the thread bobbin 48 is rotatable by pulling the thread threads wound up in it in the bobbin receiving body 47.
  • FIG. 15 is a perspective view of a portion of the further embodiment of the surgical device of the present invention shown in FIG. 14 along with a locking member formed by a removable securing clip 49.
  • This securing clip 49 which carries the word "REMOVE” - in German "REMOVE” - serves to provide additional security of the person handling the device in question.
  • the securing clip 49 namely an unintentional release of the needle valve 4 due to an unintentional rotation of the rotary member 3 is avoided.
  • the securing clip 49 acts in the mounted state on the device handle part, for example, with a protruding from its inner part or at least one end side Arret istssteg to the sliding link 25 'and / or on the receiving part 17' to the effect that in this state, a longitudinal displacement of the slide link 25th 'to the distal end device and / or a rotation of the receiving part 17' and thus the rotary member 3 are blocked.
  • a differently constructed locking or locking member could be realized in the device handle part, for example a lever device.
  • a lever device could be acted in their one adjusting position on the sliding rod 25 'and / or on the receiving part 17' in a similar manner as with the securing clip 49 in its patch on the device handle part state.
  • the lever device in question could then release the normal device functions as in the case of the assumed securing clip 49.
  • FIGS. 14 and 15 are greatly enlarged perspective views of a suture receiving device used in the further embodiment of the surgical device according to the present invention shown in FIGS. 14 and 15 with the bobbin receiving body 47 and the filament bobbin 48 rotatably received therefrom and receiving at least one suture 54 is.
  • the coil receiving body 47 preferably has on its upper side in two diametrically opposite regions recesses 50, 51, in which the sliding element rod 25 'shown in FIG. 14 and 15 after insertion of the coil receiving body 47 is guided in the middle device handle portion for longitudinal movement.
  • the bobbin receiving body 47 In order to prevent twisting of the bobbin receiving body 47 relative to the central device handle portion after such insertion of the bobbin receiving body 47 into the central device handle portion, the bobbin receiving body 47 is received with a ridge member thereof in a corresponding receiving groove extending in the apparatus Handle portion is, as shown in FIGS. 14 and 15 can be seen. Other means preventing a member from twisting against another member could also be used here.
  • Fig. 7 shows a perspective sectional view of the thread receiving device shown in Fig. 16 with a section below an upper cover plate of the bobbin 48.
  • the bobbin 48 from the upper cover plate, of which an inner cylinder 55 and an outer cylinder 56th protrude down.
  • the respective sewing thread 54 is wound, which is guided out of a slot or a bore 53 in the outer cylinder 56 and through the slot 52 from the coil receiving body 47 out.
  • the mentioned sewing thread 54 can, as stated above, be provided individually or in a plurality and accordingly wound up in the thread bobbin 48.
  • two or four sewing threads may be wound in accordance with the number of sewing needles present.
  • the threads in question can be given equal tension by the mentioned slot or bore 53.
  • the thread take-up device could also be constructed differently than has previously been explained with reference to FIGS. 16 and 17.
  • the yarn package could have only one inner cylinder and two cover plates delimiting its length.
  • FIG. 18 illustrates in a greatly enlarged sectional view a possible configuration of the distal end region of the device 1.
  • the distal end region of the insertion tube 13 is shown, in which according to the invention preferably a sealing device is housed or inserted.
  • This sealing device serves for insertion of the insertion tube 13 into a blood vessel through a tissue opening present in the latter and to be closed prevent blood from completely flowing through the insertion tube 13 and exiting from its proximal end.
  • the sealing device consists of an inserted into the insertion tube 3 distal insertion tube 43, which may for example consist of a biocompatible plastic, such as a polyamide.
  • a sealing member 44 extending over its inner diameter, which is either initially completely closed or which may be formed, for example, by a normally closed lip valve, that is to say without mechanical action.
  • a sealing member 44 which is initially completely closed, it can be pierced by means of a guide wire 45 as it passes through the insertion tube 13.
  • this opening can be done here by means of the guide wire 45 as it passes through the insertion tube 13 and the sealing member 44.
  • the possible distal end region of the device 1 shown in FIG. 18 may, of course, also be applied to the further embodiment of the surgical device according to the invention shown in FIGS. 14 and 15.
  • the above-described handling of the surgical device 1 according to the invention thus includes a method for operating a surgical device for passing at least one suture attached to a needle through the edge region of a tissue opening, optionally formed by cutting, in particular in an artery of an individual Retracting the respective suture end passed through the respective edge region from said opening.
  • the needle connected to the respective sewing thread is received and guided in a receiving and guiding opening of a rod-shaped needle receiving and guiding device in such a way that it is moved from a pushing device arranged towards the proximal end of the device to a needle receiving region at the distal end of the device over a gap region a length corresponding at least to the thickness of the wall of the tissue opening and having an outer shape reduced relative to the outer shape of the needle receiving and guiding device for unimpeded movement of the respective needle from the needle receiving and guiding device to the distal end of the device.
  • the respective needle is thereby passed through moved the edge region of the relevant tissue opening in the needle receiving area for local permanent recording.
  • the rod-shaped Nadel effectiveness- and needle guide device is withdrawn together with the respective needle in the needle receiving area permanently recorded and connected to this end of the suture from the said tissue opening again.
  • the respective needle received by the needle receiving portion of the rod-shaped needle receiving and sewing needle guide means is stretched by the distal end of the device and compressible around a longitudinal body portion in a device longitudinal direction and stretchable in a longitudinal direction opposite thereto in its compressed state a braid interior formed by the compression inserted and after such needle receiving by subsequent stretching of the braid of this enclosed and held.
  • the upsetting and stretching of the braid is preferably by means of a Dreh°.
  • a Dreh° causes rotational movement of said rotary member, the rotational movement is converted into a longitudinal or translational movement.
  • a release / blocking function for the movement / blocking of the movement of the needle pusher is preferably connected to this rotary or rotational movement.
  • the respective needle with the sewing thread connected to it by means of the needle pusher can be led out of the distal end of the needle receiving and needle guide device 5 only after the mesh 9 has been compressed to form a mesh interior.
  • the formation of the mesh interior occurs with proper handling of the described surgical device 1 within each tissue opening to be closed. As a result, safe handling of the described surgical device 1 is thus ensured.
  • a number of needles different from four needles and sewing thread ends connected thereto may be used, such as with two or three such sewing needles, or in principle with at least one needle and sewing thread attached thereto, to this sewing thread by means of the associated needle through the border region of a tissue opening present in particular in an artery of an individual.
  • a number of needles different from four needles and sewing thread ends connected thereto may be used, such as with two or three such sewing needles, or in principle with at least one needle and sewing thread attached thereto, to this sewing thread by means of the associated needle through the border region of a tissue opening present in particular in an artery of an individual.
  • the release / locking mechanism for releasing or inhibiting the displacement of the respective needle may be formed in a manner different from that described above.
  • the needle slide 4 could be locked or unlocked in its displaceability by a locking / unlocking pin which can be displaced transversely to the longitudinal direction of the device 1, ie be released.
  • the above-described conversion device with the aid of which the rotational or rotational movement of the rotary part 3 is converted into a longitudinal or translational movement for compressing the braid 9, can be realized in a different way than explained.
  • the functions of the sliding part 14, which has at least one thread in its cylinder circumference, and the pin element 22 associated with the respective thread could be reversed in accordance with a kinematic reversal.
  • a pin element corresponding to the respective pin element 22 would be connected to the above-mentioned longitudinal bar, and an internally threaded portion of a hollow cylindrical rotary member corresponding to the sliding portion 14 would engage the respective pin element with at least one internal thread.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Surgical Instruments (AREA)

Abstract

Pour guider au moins un fil de suture (10) fixé à une aiguille (11) à travers la zone périphérique d'une ouverture tissulaire, puis pour retirer hors de l'ouverture tissulaire le fil de suture traversant ladite zone périphérique, le dispositif chirurgical de l'invention comprend un dispositif de logement et de guidage d'aiguille (5) en forme de tige, dans lequel l'aiguille (11) est mobile au moyen d'un dispositif coulissant, en direction d'une zone de logement d'aiguille à l'extrémité distale du dispositif, en passant par une zone intermédiaire (12) qui présente une longueur correspondant au moins à l'épaisseur de la paroi de l'ouverture tissulaire et, relativement à la forme externe du dispositif de logement et de guidage d'aiguille, une forme externe réduite pour ne pas gêner le mouvement de l'aiguille (11) du dispositif de logement et de guidage d'aiguille (5) vers l'extrémité distale du dispositif. L'extrémité distale du dispositif est pourvue d'une zone de logement d'aiguille avec un entrelacement de fils (9) qui peut être comprimé ou étiré dans le sens longitudinal du dispositif et dans lequel l'aiguille (11) est maintenue en permanence après avoir traversé la zone périphérique de l'ouverture tissulaire.
PCT/DE2010/001243 2009-10-23 2010-10-22 Dispositif chirurgical permettant de guider au moins un fil de suture à travers la zone périphérique d'une ouverture tissulaire d'un patient et procédé d'actionnement d'un tel dispositif WO2011047672A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP10784675A EP2490596A1 (fr) 2009-10-23 2010-10-22 Dispositif chirurgical permettant de guider au moins un fil de suture à travers la zone périphérique d'une ouverture tissulaire d'un patient et procédé d'actionnement d'un tel dispositif
US12/998,782 US20110230899A1 (en) 2009-10-23 2010-10-22 Surgical device for feeding at least one suture thread through the edge area of a tissue opening of an individual and method for operating such a device
DE112010004777T DE112010004777A5 (de) 2009-10-23 2010-10-22 Chirurgische vorrichtung zum hindurchführen wenigstens eines nähfadens durch den randbereich einer gewebeöffnung eines individuums und verfahren zum betätigen einer solchen vorrichtung

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009050457A DE102009050457A1 (de) 2009-10-23 2009-10-23 Chirurgische Vorrichtung zum Hindurchführen wenigstens eines Nähfadens durch den Randbereich einer Gewebeöffnung eines Individuums und Verfahren zum Betätigen einer solchen Vorrichtung
DE102009050457.5 2009-10-23

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WO2011047672A1 true WO2011047672A1 (fr) 2011-04-28

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PCT/DE2010/001243 WO2011047672A1 (fr) 2009-10-23 2010-10-22 Dispositif chirurgical permettant de guider au moins un fil de suture à travers la zone périphérique d'une ouverture tissulaire d'un patient et procédé d'actionnement d'un tel dispositif

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US (1) US20110230899A1 (fr)
EP (1) EP2490596A1 (fr)
DE (2) DE102009050457A1 (fr)
WO (1) WO2011047672A1 (fr)

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US5417699A (en) 1992-12-10 1995-05-23 Perclose Incorporated Device and method for the percutaneous suturing of a vascular puncture site
US5496332A (en) * 1994-10-20 1996-03-05 Cordis Corporation Wound closure apparatus and method for its use
WO1999012480A1 (fr) 1997-09-10 1999-03-18 Applied Medical Resources Corporation Procede et appareil de suture
WO1999025254A1 (fr) 1997-11-19 1999-05-27 Applied Medical Resources Corporation Appareil de suture ameliore et procede associe
DE19942951C1 (de) 1999-09-08 2001-01-18 Gip Medizin Technik Gmbh Vorrichtung zum Hindurchführen wenigstens zweier Nähfäden durch eine Wandung, insbesondere einer Arterie eines Individuums, nahe des Randbereiches einer darin vorhandenen Öffnung
DE69729920T2 (de) 1996-09-19 2005-08-25 Medtronic AVE, Inc., Santa Rosa Vorrichtung zum Verschliessen einer Wunde
DE102004041936B3 (de) 2004-08-30 2005-10-06 Medi-Globe Gmbh Chirurgische Vorrichtung zum Hindurchführen wenigstens zweier Nähfäden durch den Randbereich einer Gewebeöffnung
WO2007025302A2 (fr) * 2005-08-26 2007-03-01 G-Surge Medical Solutions, Inc. Appareil et procedes de suture
DE69637177T2 (de) 1995-07-14 2008-04-03 Medtronic Vascular, Inc., Santa Rosa Vorrichtung zum verschliessen einer wunde

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EP1331889A1 (fr) * 2000-09-01 2003-08-06 Advanced Vascular Technologies LLC Instrument de mise en place d'une greffe de derivation vasculaire
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US5304184A (en) 1992-10-19 1994-04-19 Indiana University Foundation Apparatus and method for positive closure of an internal tissue membrane opening
DE69332912T2 (de) 1992-10-19 2004-02-12 Advanced Research & Technology Institute, Bloomington Vorrichtung zum verschliessen einer öffnung in einer gewebe-membran im körperinneren
US5417699A (en) 1992-12-10 1995-05-23 Perclose Incorporated Device and method for the percutaneous suturing of a vascular puncture site
DE69334017T2 (de) 1992-12-10 2007-01-25 Abbott Laboratories, Abbott Park Vorrichtung zum Nähen einer Punktionsstelle in einem Blutgefäss
US5496332A (en) * 1994-10-20 1996-03-05 Cordis Corporation Wound closure apparatus and method for its use
DE69637177T2 (de) 1995-07-14 2008-04-03 Medtronic Vascular, Inc., Santa Rosa Vorrichtung zum verschliessen einer wunde
DE69729920T2 (de) 1996-09-19 2005-08-25 Medtronic AVE, Inc., Santa Rosa Vorrichtung zum Verschliessen einer Wunde
WO1999012480A1 (fr) 1997-09-10 1999-03-18 Applied Medical Resources Corporation Procede et appareil de suture
WO1999025254A1 (fr) 1997-11-19 1999-05-27 Applied Medical Resources Corporation Appareil de suture ameliore et procede associe
DE19942951C1 (de) 1999-09-08 2001-01-18 Gip Medizin Technik Gmbh Vorrichtung zum Hindurchführen wenigstens zweier Nähfäden durch eine Wandung, insbesondere einer Arterie eines Individuums, nahe des Randbereiches einer darin vorhandenen Öffnung
DE102004041936B3 (de) 2004-08-30 2005-10-06 Medi-Globe Gmbh Chirurgische Vorrichtung zum Hindurchführen wenigstens zweier Nähfäden durch den Randbereich einer Gewebeöffnung
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US20110230899A1 (en) 2011-09-22
DE112010004777A5 (de) 2012-10-31
DE102009050457A1 (de) 2011-05-05
EP2490596A1 (fr) 2012-08-29

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